Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

in vitro bacteria test, OECD 471 with nitro-reductasi deficient strains: negative (further evidence needed)


in vitro gene mutation in mammalian cells, negative

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

in vivo cytogenicity (micronucleus), negative


in vivo UDS, OECD 486, negative


in vivo Comet Assay, analoge substance, testing proposed


 

Additional information

For further details refer to the attached document on genotoxicity assessment

Justification for classification or non-classification

Classification for mutagenicity is warranted for substances which cause concern for humans owing to the possibility that they may


induce heritable mutations in the germ cells of humans


The classification in Category 2 is based on:


— positive evidence obtained from experiments in mammals and/or in some cases


from in vitro experiments, obtained from:


— somatic cell mutagenicity tests in vivo, in mammals; or


— other in vivo somatic cell genotoxicity tests which are supported by


positive results from in vitro mutagenicity assays.


Based on the results of the in vitro tests and the actual information on genotoxicity no classification for mutagenicity is applied following Regulation 1272/2008.


A new evaluation of the genotoxic potential is performed once the results of the in vivo Comet Assay on the analogue substance 3 will be available